Metabolic syndrome is a metabolic disease characterized by the presence of several of the following risk factors: hyperglycemia, hypertension, low high-density lipoprotein (HDL), high low-density lipoprotein (LDL), high triglyceride, and abnormal body mass index (BMI), micro-albuminuria, endothelial dysfunction, pro-thrombotic state, and inflammatory process. Although not all these criteria need to be met before a diagnosis of the disease may be found, three occurrences of these symptoms may be found indicative of the syndrome.
It is estimated that over 22% of the adult U.S. population have metabolic syndrome and the incidence is rapidly increasing. Old age, postmenopausal status, ethnicity, higher body mass index, smoking, low household income, high carbohydrate intake, and physical inactivity all have been connected with the increased odds of the onset and or deterioration of metabolic syndrome. An additional 12 million adults will likely develop the syndrome as a result of aging alone by 2022.
A single cause at the molecular level cannot be traced to the origin of metabolic syndrome. However, increasing evidence suggests the disease originates from both insulin resistance and activation of vascular inflammatory mechanisms related to increased oxidative stress. For example, insulin resistance results in preferential metabolism of free fatty acids, which leads to reduced glucose utilization. Insulin resistance is identified in children prior to the development of the dyslipidemia, hypertension and hyperglycemia that occur later in life. As one ages, pancreatic beta cell exhaustion is not able to meet insulin resistance demands, and this might eventually lead to the progression of metabolic disturbance including dyslipidemia, hypertension, etc. On the other hand, the infiltration of adipose tissue by inflammatory macrophages has been indicated as a common feature of obesity. Adipose mass, as measured by weight, body mass index (BMI) or visceral obesity, correlates quantitatively with genetic expression of macrophages that produce inflammatory mediators and markers. Other distinct factors and causes are also involved.
All in all, the treatments for metabolic syndrome vary greatly. Many times, a person diagnosed with several risk factors as discussed above would be prescribed a low fat diet, exercise regime, and pharmaceutical intervention including a host of drugs to individually combat issues with cholesterol, blood pressure, glucose, and body weight. Due to the complicated nature of such therapy, compliance is often low.
Therefore, and in view of the fact that metabolic syndrome is distinguishable in cause and effect from diabetes, prior studies do not teach a treatment for pathological states such as hypertension and hyperglycemia in subjects who are not already diabetic; nor do they support a method to concurrently reduce and improve two to three or more risk factors associated with the metabolic syndrome even in diabetic subjects. Furthermore, prior studies fail to provide a useful teaching on how to eliminate a risk factor or reverse these metabolic conditions in people that have not fully developed any disease state.
To date, prior studies have not provided any therapeutic materials that can specifically address metabolic syndrome, nor the mechanisms leading up to the development of the metabolic syndrome. Therapies have been directed to the treatment of specific features of the syndrome on an individual basis, and not to any holistic therapy. As will be explained in detail, the present invention recognizes that particular Nelumbo-derived compositions are effective in simultaneously controlling multiple pathologies and pathways leading to the development of metabolic syndrome. Furthermore, the therapeutic compositions and processes described herein are simple to implement and conducive to good patient compliance.